Rabies Vaccine Trial (RAB001)
***THIS STUDY HAS NOW FULLY RECRUITED.
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FOR OUR CURRENTLY RECRUITING TRIALS***
What is the purpose of this trial?
The purpose of this study is to test a new vaccine against Rabies in healthy volunteers.
The belief that rabies is a disease of the past is incorrect. Rabies causes up to 60 000 deaths each year, with over a million people being treated for possible exposure, mostly in Africa and Asia. In these regions, treatment is prohibitively expensive, representing over a month’s salary for most people. There are vaccines currently available, but they are difficult to manufacture and expensive, and not widely used in the regions where rabies exposure it highest.
The new vaccine would be cheap and easy to manufacture, allowing global control of rabies for the first time. This study will enable us to assess the safety of the vaccine and the extent of the immune response in healthy volunteers. We will do this by giving participants one dose of the new vaccine. In addition, volunteers will also be offered the opportunity to receive 3 doses of a currently available vaccine, offering full vaccination against rabies.
What does the trial involve?
The trial involves receiving one dose of a vaccine (ChAdOx2 RabG) and attending a series of follow-up visits after vaccination. You will be asked to fill in an electronic diary card to tell us about any symptoms you have after vaccination and will be required to have blood taken at most of the follow-up visits.
You will have the opportunity to take part in a second period of follow-up involving receiving 3 doses of a currently available vaccine against rabies and having blood taken at visits.
During each study visit, we would also like to collect a sample of saliva in order to measure common, non-rabies viruses. Providing saliva is optional, and you can still take part in the trial if you do not provide saliva samples.
Is there any reimbursement for the trial?
Yes, you will be reimbursed at set rates for your time, inconvenience and travel which for this study will be up to £335 for all participants, rising to £605 if you choose to return for the second period of follow-up involving current rabies vaccinations. For full details of the reimbursement provided, read the participant information sheet.
What are the advantages of taking part?
By taking part, you will make an important contribution to the knowledge which may aid in the development of a more effective vaccine against Rabies. Such as vaccine would improve the health and economic live of millions of people.
You will also be able to get information about your general health during the pre-enrolment process. If you choose to participate in the second period of follow up, you will receive the existing rabies vaccine and will therefore be vaccinated against rabies following current UK recommendations.
Are there any risks from taking part in the study?
We do not expect the side effects to be significantly different from numerous trials we have conducted using similar vaccines, however, this will be the first time this vaccine has been given to humans. Please refer to the trial information sheet for full details of procedures and potential risks.
What will happen if I don’t want to carry on with the study?
Participation is voluntary and you are free to change your mind and withdraw at any time. This will not affect your subsequent medical care in any way. If you withdraw we might need to offer you a follow up visit, for example to check the vaccination site or a blood result. Your compensation would be paid as a proportion of the total compensation according to the length of your participation.